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Summit, United States Tsr Consulting Services Inc. Full timeTSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading Pharmaceutical company is hiring a MES Validation Specialist.Job ID #80107 Rate type: W2 only CommentsMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be available onsite when manager...
Validation Engineer || Pharma
2 months ago
Job Description
Job Description
Must Haves:
*Implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites
*Capable of taking Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
Education and Experience:
• Required BS degree in Engineering / Computer Science
• Minimum 5 years of experience in FDA-regulated industry, with min 3 years’ experience in CSV
DUTIES AND RESPONSIBILITIES:
Essential Functions:
Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures.
• Develops protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment qualifications and validation protocols.
• Supervises vendors for qualification functions.
• Supports calibration, equipment qualification and validation activities.
• Configures and documents the configuration of computerized systems.
• Develops
validation/qualification
deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Manages projects of varying scope and complexity.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
• Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
• Completes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.
• Provides excellent customer service and support.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Company Description Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.
Company Description
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money.
Synkriom leads the industry with experience authentication of candidates.
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